Inspections, Compliance, Enforcement, and Criminal Investigations
Hull Veterinary Clinic, PC 10-Oct-08
Department of Health and Human Services
Public Health Service
Kansas City District
October 10, 2008
RETURN RECEIPT REQUESTED
Ref: KAN 2009-01
LaVerne O. Sheldahl, DVM, President
Michael D. Bomgaars, DVM, Vice-President
Hull Veterinary Clinic, PC
213 Black Forest Road
Hull, Iowa 51239
Dear Drs. Sheldahl and Bomgaars:
On April 23, April 29, and May 6, 2008, an investigator from the U.S. Food and Drug Administration (FDA), conducted an investigation regarding the use of drugs in your veterinary practice located in Hull, Iowa. On August 27, 2008, the agency collected additional documentation relating to the investigation. Our investigation revealed that you caused the new animal drug sulfachlorpyridazine and the human drug amoxicillin to be unsafe under section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §360b(a)(1), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. §351(a)(5), because you used the drugs in a manner that did not conform with their approved uses or the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations (21 CFR), Part 530 (21 CFR Part 530). In addition, our investigation revealed that you caused animal feed to be unsafe under section 512(a)(2) of the Act, 21 U.S.C. §360b(a)(2), and adulterated within the meaning of section 501(a)(6) of the Act, 21 U.S.C. §351(a)(6). You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
The extralabel use of approved veterinary or human drugs in animals is permitted only if it complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. §360b(a)(4) and (5), and the implementing regulations at 21 CFR Part 530. Our investigation found that you failed to comply with these requirements. For example, you and/or clinic personnel under your direction:
• Sold the approved human drug amoxicillin for oral suspension for extralabel use to farms without the valid veterinary/client/patient/relationship required by 21 CFR 530.10(a). Specifically you sold amoxicillin to [(b)(4)] on numerous occasions documented from 2003 to 2008. No veterinarian from this clinic had visited the farm since 1998.
• Compounded a sulfachlorpyridazine solution ("Vetisulid Injection") from Vetisulid® brand of sodium sulfachlorpyridazine oral powder and sold this product to be used as an intravenous injection to treat mastitis in lactating dairy cows. Vetisulid® Powder brand of sodium sulfachlorpyridazine is labeled for oral use in calves and swine. Extralabel use of sulfonamide drugs in lactating dairy cows is prohibited under 21 CFR 530.41(a)(9).
• Compounded a product (Vetisulid Injection) from Vetisulid® brand of sodium sulfachlorpyridazine oral powder and then used and sold this compounded product for oral and intramuscular administration to treat diarrhea in calves, despite there already being approved oral and injectable products to treat diarrhea in calves. Under 21 CFR 530.13(b)(2), the extralabel use from compounding of approved new animal or human drugs is permitted only if there is no approved new animal or approved new human drug that, when used as labeled or in conformity with criteria established in Part 530 (legal extralabel use), will, in the available dosage form and concentration, appropriately treat the condition diagnosed.
• Compounded a product (Vetisulid Injection) from Vetisulid® brand of sodium sulfachlorpyridazine oral powder and then used and sold the compounded product for use in milk replacer, an animal feed, to treat diarrhea in baby calves. Although the Vetisulid® brand of sodium sulfachlorpyridazine oral powder is approved for treatment of diarrhea in baby calves, your clinic did not use the Vetisulid® powder in accordance with its approved labeling or the requirements of 21 CFR Part 530. For example, you and/or clinic personnel under your direction diluted the Vetisulid® powder with sterile water rather than adding it directly to milk or milk replacer as provided in the approved labeling. In addition, your compounded product is labeled with a different oral dosage than the approved product and your compounded product is premixed sometimes months in advance even though the approved product labeling specifies that fresh solution is to be prepared at the time of use. Because your clinic's use or intended use of the Vetisulid® brand of sodium sulfachlorpyridazine oral powder is not in accordance with the approved labeling for this product, it is an extralabel use. Although some extralabel use in animals of approved new animal and human drugs is permitted, extralabel use of such drugs in or on an animal feed is specifically prohibited by section 512(a)(4) of the Act, 21 U.S.C. 360b(a)(4), and the regulations at 21 CFR 530.11(b).
Because your extralabel use of the human drug amoxicillin and the new animal drug sulfachlorpyridazine was not in compliance with 21 CFR Part 530, you caused these drugs to become unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5). In addition, by adding the Vetisulid Injection product compounded by your clinic to milk replacer in violation of 21 CFR 530.11(b), you caused that animal feed to become unsafe under section 512(a)(2) of the Act, 21 U.S.C. 360b(a)(2), and adulterated under section 501(a)(6) of the Act, 21 U.S.C. 351(a)(6).
The above is not intended to be an all-inclusive list of violations. You are responsible for complying with the requirements of the Act, and the extralabel use regulations promulgated under the Act. You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
We have enclosed a copy of 21 CFR Part 530 for your reference. We strongly suggest that you review this document and become familiar with all of the requirements concerning extralabel use of new animal and human drugs so that you can prevent future violations of the Act.
You should notify this office in writing of the specific steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Amy E. Devine, Compliance Officer, U.S. Food and Drug Administration, at 11630 West 80th Street Lenexa, Kansas 66214-3340. If you have any questions about this letter, please contact Compliance Officer Devine at this address or (913) 752-2100.
John W. Thorsky
Kansas City District
cc: Dr. David Schmitt, DVM, State Veterinarian
Iowa Board of Veterinary Medicine
Wallace Building, 2nd Floor
East 9th and Grand
Des Moines, Iowa 50319
Lloyd K. Jessen, R.Ph., J.D.
Iowa Board of Pharmacy
400 SW Eighth Street, Suite E
Des Moines, Iowa 50319